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Industry Group Sues HHS for Applying Medicaid Rebate Rule to Radiopharmaceuticals

March 22, 2018

The Council on Radionuclides and Radiopharmaceuticals sued HHS arguing it improperly interpreted the 2016 Medicaid rebate program final rule by applying it to radiopharmaceutical products.

In a complaint filed in District of Columbia District Court CORAR argued there are significant differences in the packaging, administration, and reimbursement methodologies for radiopharmaceuticals relative to more traditional pharmaceutical products.

The council said their inclusion is a major burden for radiopharmaceutical manufacturers because it requires them to enter a rebate deal with the Centers for Medicare and Medicaid Services in order to receive Medicaid reimbursement for their products as well as obligating them to report data back to CMS.

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